Predicting prevalence and severity of cytokine release syndrome after chimeric antigen receptor (CAR) T-cell therapy in patients with autoimmune disease: a retrospective cohort study
Authors' conclusion
Higher baseline B-cell counts and systemic inflammation are associated with the development of CRS after CAR T-cell therapy in patients with autoimmune diseases.
Study context
- Population
- Patients with autoimmune diseases treated with autologous CAR T-cell therapy (CD19, or CD19-BCMA in China), six centres in Germany and one in China, March 2021–July 202576 women · 32 men
- Participants
- 108 patients
- Exposure
- Patients who developed cytokine release syndrome (CRS) vs patients without CRS after CAR T-cell therapy
- CRSn = 86
- Outcome
- Occurrence of CRS and ICANS (severity by American Society for Transplantation and Cellular Therapy criteria)
Methodological detailsmulticentre (six centres in Germany, one in China), multivariable logistic regression
- Multicentre (six centres in Germany, one in China)
- Multivariable logistic regression
Main finding
As reported in the abstract
- CRS after CAR T-cell therapy
- 86 (80%) of 108
- CRS grade 1
- 71 [66%]
- CRS grade 2
- 14 [13%]
- CRS grade 3
- 1 [1%]
- ICANS
- 3 (3%)
- ICANS grade 1
- 2 [2%]
- ICANS grade 2
- 1 [1%]
Observational data: associations, not effects.
Further findings
Baseline B-cell count
P = 0.0002
Baseline IL-6 concentration
P = 0.0003
Baseline CRP concentration
P = 0.042
Factors associated with CRS (multivariable logistic regression)
| OR (95% CI) | P value | ||
|---|---|---|---|
| B-cell counts | 1.31 (1.06–1.67) | P = 0.012 | |
| IL-6 concentrations | 2.28 (1.30–4.65) | P = 0.0001 | |
| 0.20.5125Odds ratio (log scale) |
Original publication
Predicting prevalence and severity of cytokine release syndrome after CAR T-cell therapy in patients with autoimmune disease: a retrospective cohort study. Lancet Rheumatol. Published 25 September 2026. doi:10.
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